Prepared based on a systems engineering approach, best practices, the company’s current operations, and the requirements of the TS EN ISO 13485 standard for medical devices – Quality Management Systems, the NÜVE Product Development Procedure was introduced at a launch meeting held on May 18, 2023.
In the first session, attended by NÜVE’s management and representatives from all departments involved in the product development process, information was provided on the creation process and content of the “Product Development Procedure.”
In the second session, feedback was gathered from department representatives through flowcharts covering each stage of the product development process, including “requirements definition,” “concept development,” “preliminary design,” “detailed design,” “prototype production,” “verification,” and “validation.”
We wish for this procedure, which will be finalized by incorporating recorded feedback, to be beneficial for NÜVE.
This procedure, defining the framework of the product development process, activities within the process, responsibilities, and the inputs and outputs for these activities, marks an important step in NÜVE’s corporate transformation journey.
We extend our gratitude to the entire NÜVE team for their dedicated efforts and collaboration during the creation of this procedure.